Infant CPAP nasal cannula seal

ABSTRACT

A method and assembly for attaching a flexible longitudinal medical element to the face of a patient by providing a polymer strip having adhesive material on one side and hook material on the other. Also, a strip of loop material is affixed about the flexible longitudinal element. The loop material is engaged to and secured by the hook material, thereby affixing the flexible longitudinal element to the patient&#39;s face, at a desired location.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of application Ser. No. 10/667,728, filed Sep.22, 2003.

BACKGROUND OF THE INVENTION

An issue may arise when attaching a respiratory tube to a patient of finding a attachment location additional to the nose itself to attach the device so that the but stays correctly oriented relative to the nose. This problem is also encountered in the attachment, in general, of flexible longitudinal medical elements to a patient's face.

SUMMARY

The present invention is a method and assembly for attaching a flexible longitudinal medical element to the face of a patient by providing a polymer strip having adhesive material on one side and hook material on the other. Also, a strip of loop material is affixed about the flexible longitudinal element. The loop material is engaged to and secured by the hook material, thereby affixing the flexible longitudinal element to the patient's face, at a desired location.

The foregoing and other objectives, features and advantages of the invention will be more readily understood upon consideration of the following detailed description of the preferred embodiment(s), taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of an infant nasal CPAP cannula seal according to the present invention.

FIG. 2 is a cross-sectional view of the infant nasal CPAP cannula seal of FIG. 1, taken along line 2-2 of FIG. 1.

FIG. 3A is an illustration of opening an antiseptic container in a method of using a CPAP cannula seal according to the present invention.

FIG. 3B is an illustration of peeling a cannula seal from its releasable liner in a method of using a CPAP cannula seal according to the present invention.

FIG. 3C is an illustration of carrying a cannula seal to an infant's face in a method of using a CPAP cannula seal according to the present invention.

FIG. 3D is an illustration of placing a cannula seal on an infant's face in a method of using a CPAP cannula seal according to the present invention.

FIG. 3E is an illustration of placing a cannula seal over an infant's nose in a method of using the CPAP cannula seal according to the present invention.

FIG. 4A is an illustration of placing a strip of loop material about a cannula in a method of using a CPAP cannula seal according to the present invention.

FIG. 4B is an illustration of placing an additional loop material about a cannula in a method of using a CPAP cannula seal according to the present invention.

FIG. 4C is an illustration of a CPAP cannula seal having strips of loop material applied to, which represents a stage in a method of using a CPAP cannula seal according to the present invention.

FIG. 5A is an illustration of an alternative CPAP cannula seal assembly according to the present invention, in which the releasable liner assembly includes a first releasable liner, and a second releasable liner overlaps said first releasable liner.

FIG. 5B is an illustration of an alternative CPAP cannula seal assembly according to the present invention, in which the releasable liner assembly includes a releasable liner and a tab.

FIG. SC is an illustration of an alternative CPAP cannula seal assembly according to the present invention, in which the releasable liner assembly includes a releasable liner that is cut into parts.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

One embodiment of the present invention is a nasal CPAP seal 10 (FIG. 1). Referring to FIG. 2, seal 10 is made principally of a 25 micrometer thick strip of flexible polyurethane 12 having a hydrocolloid 14 (FIG. 2) laminated to it. Unlike CPAP seals that are cut out of wound dressing, seal 10 is semi-transparent. Wound dressing, because it is placed directly on an open wound, must be sterilized and because of its composition the only practical way of doing this is by bombarding it with gamma rays, which causes it to become opaque. Seal 10, however, is not intended for use in treating open wounds, but rather to be placed on intact skin and mucous membrane. Although the manufacturing process is sanitary, there is no need to sterilize the seals 10, allowing the production of a translucent, semi-transparent seal 10, which permits inspection of the underlying skin and mucous membrane. As noted in the Background section this inspection is extremely important in the prevention of skin necrosis due to an imperfectly applied seal and in the prevention of nasal passageway closure, due to mucous build-up, which is a potentially life threatening condition.

Seal 10, which is between 10 mm and 15 mm long and between 3 mm and 10 mm wide, includes a pair of adherence wings 16, for gently fixing the seal 10 onto the cheeks of an infant patient and a lip covering region 18 for adherence to the upper lip. Toward the center of seal 10, a nose-covering region 20 defines a pair of apertures 22, which are between 2 mm and 4.5 mm in major axis length and are spaced apart by from 1.5 mm to 3 mm, and are adapted to accommodate a pair of terminal air channels 24 (FIGS. 4A-4C) of the CPAP cannula 26 (FIGS. 4A-4C) . Although these apertures are shown as being round, an alternative preferred embodiment they are D-shaped. Significantly, a set of radially outwardly extending cuts or stellations 28 emanate from each aperture 22 (FIG. 1). Not only do stellations 28 permit apertures 22 to accommodate any one of a few different cannula makes, as the cannula is inserted through aperture 22, a set of tabs 30 defined by the stellations 28 are pushed inwardly so that they extend into the infant's nostrils, contacting and providing gentle support to the delicate intranasal mucous membrane. Only very small stellations 28 emanate from the septum side of the apertures 22, to avoid weakening the thin strip of material between the apertures 22.

The nose-covering region 2Q is defined, in part by a pair of cuts 32, which facilitate region 20 in being folded upwardly relative to the lip adherence region 18 and wings 16. Some embodiments do not include cuts 32, as the wound dressing material is quite flexible and compressible.

A v-shaped cleft 34 is defined by region 20 and helps region 20 fold in about the infant nose. In addition, a strip of hook material 50 is present on the lower part of lip covering region 18 and wings 16. Material 50 is used to attach seal 10 to the cannula 26, which is fitted with a pair of loop material strips 54 (FIGS. 4A-4C).

In addition material 50 imparts structural rigidity to seal 10, which is of value in the handling of seal 10.

A set of differently sized nasal CPAP seals of this make will be sold to accommodate various sizes of CPAP cannulas. It is anticipated that medical personnel will keep a range of seals on hand and pick an appropriate sized seal when needed.

Referring to FIGS. 3A-3E, a seal 10 is used by first removing it from a releasable liner 70 (FIG. 3B). It should be noted that liner 70 is not the same size and shape as seal 10, as it would be if seal and liner were simultaneously cut from the same piece of wound dressing, as is the current practice. As liner 70 extends outwardly beyond the limits of seal 10, it is easier for a user to first grasp liner 70 and then pry seal 10 free of it. In a neo-natal care unit setting where every second can make a difference to the health of the infant, this ease of use could well be a life saving feature in some instances. Next (FIG. 3C) seal 10 is supported in transport to the infant's face, so that adhering portions do not adhere to each other. Then, wings 16 are pressed into the infant patients cheeks (FIG. 3D). Finally nose-covering region 20 is folded upwardly to cover the infant nose, nostril apertures 22 are lined up with the nostrils (FIG. 3E) and region 20 is folded over the infant nose thereby closing cleft 34. Finally, terminal air channels 24 are fitted into nostril apertures 22 and loop material 54 (FIG. 4C) is mated to hook material 50 to keep cannula 26 supported and in place.

Referring to FIG. 5A, in an alternative preferred embodiment, a release liner assembly 80 is made up of two a first release liner 82, having a portion that is folded upwardly to provide a free area 86 and a second release liner 84, which overlaps liner 82, thereby providing a second free area 88 that a user may grasp in removing the second liner from the seal 10. FIG. 5B shows yet another release liner assembly 90 in which a tab 92 is interposed between release liner 84 and seal 10. In use tab 92 is grasped by a user and used to peel the release liner 84 away from seal 10. FIG. 5C shows a still further release liner assembly 100 having a first release 102 and a second release liner 104. When assembly 100 is bent and bowed outwardly, liners 102 and 104 partially separate from seal 10 to form a pair of free areas 1Q6.

The terms and expressions that have been employed in the foregoing specification are used as terms of description and not of limitation. There is no intention, in the use of such terms and expressions, of excluding equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims which follow. 

1. A method of securing a flexible longitudinal medical element to a patient's face, comprising: (a) providing a polymer strip having adherent material on a first side and hook material on a second side; (b) adhering said adherent side of said polymer strip onto an area of said patient's face, where it is desired to secure said flexible longitudinal medical element; (c) securing a strip of loop material about said flexible longitudinal medical element; and (d) engaging said loop material to said hook material, thereby engaging said flexible longitudinal medical element to said polymer strip and by way of said polymer strip, to said patient's face, at said desired location.
 2. The method of claim 1, wherein said polymer strip forms a part of a nasal continuous positive airway pressure (CPAP) seal, also including a portion adapted to cover a patient's nose, but defining nostril apertures to permit breathing.
 3. The method of claim 2, wherein said nasal CPAP seal is an infant nasal CPAP seal, sized to fit the face of an infant.
 4. The method of claim 1, wherein said flexible longitudinal element is a respiratory tube, adapted to deliver air or oxygen to a patient.
 5. The method of claim 4, wherein said respiratory tube is a CPAP tube.
 6. The method of claim 5, wherein said CPAP tube is a nasal CPAP tube.
 7. The method of claim 1, wherein said polymer strip is placed on said patient's upper lip area.
 8. An assembly adapted to facilitate the retention of a flexible longitudinal medical element to a patient's face, comprising: (a) a polymer strip having adherent material on a first side and hook material on a second side, said adherent material being adhered to an area of a patient's face at a location where it is desired to secure said flexible longitudinal medical element; (b) providing a flexible longitudinal medical element having a strip of loop material secured around it; and (c) wherein said loop material is engaged to and thereby secured to said hook material thereby engaging said respiratory tube to said polymer strip and by way of said polymer strip, to said patient's face, at said desired location.
 9. The assembly of claim 8, wherein said polymer strip forms a part of a nasal continuous positive airway pressure (CPAP) seal, also including a portion adapted to cover a patient's nose, but defining nostril apertures to permit breathing.
 10. The assembly of claim 9, wherein said nasal CPAP seal is an infant nasal CPAP seal, sized to fit the face of an infant.
 11. The assembly of claim 8, wherein said flexible longitudinal element is a respiratory tube, adapted to deliver air or oxygen to a patient.
 12. The assembly of claim 11, wherein said respiratory tube is a CPAP tube.
 13. The assembly of claim 12, wherein said CPAP tube is a nasal CPAP tube.
 14. The assembly of claim 8, wherein said polymer strip is placed on said patient's upper lip area. 